- Approval Id
- 786b47d38eebbe3a
- Drug Name
- BOOSTRIX POLIO SUSPENSION FOR INJECTION
- Product Name
- BOOSTRIX POLIO SUSPENSION FOR INJECTION
- Approval Number
- SIN15888P
- Approval Date
- 2020-02-20
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- **Dosage and Administration**
**Posology**
A single 0.5 ml dose of the vaccine is recommended.
Boostrix Polio may be administered from the age of three years onwards. Boostrix Polio should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines with reduced content of diphtheria toxoid plus tetanus toxoid in combination with pertussis and poliomyelitis antigens.
Boostrix Polio can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see _Pregnancy_ and _Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Boostrix Polio may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus, pertussis and polio (see _Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus.
Boostrix Polio can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.
Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations (generally 10 years).
**Method of administration**
Boostrix Polio is for deep intramuscular injection, preferably in the deltoid region (see also _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **Indications**
Boostrix Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see _Posology_).
The use of Boostrix Polio should be in accordance with official recommendations.
- Contraindications
- **Contraindications**
Boostrix Polio should not be administered to subjects with known hypersensitivity to any component of the vaccine (see _Quantitative and Qualitative composition_ and _List of Excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines.
Boostrix Polio is contraindicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus and poliomyelitis vaccines.
Boostrix Polio should not be administered to subjects who have experienced neurological complications following an earlier immunisation against diphtheria and/or tetanus (for convulsions or hypotonic-hyporesponsive episodes, see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- J07CA02
- Atc Item Name
- diphtheria-pertussis-poliomyelitis-tetanus
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd
